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510(k) Data Aggregation
K Number
K232488Device Name
Accu-Chek Safe-T-Pro Plus Lancing Device
Manufacturer
Roche Diabetes Care, Inc.
Date Cleared
2023-11-13
(88 days)
Product Code
FMK, QRK, QRL
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Roche Diabetes Care, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Accu-Chek Safe-T-Pro Plus lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.
Device Description
The Accu-Chek Safe-T-Pro Plus lancing device is a sterile, single-use, disposable lancing device intended to be used by non-professional users 18 years and older and healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel. The Accu-Chek Safe-T-Pro Plus lancing device is a needle used for capillary blood sampling for use in diagnostic testing. The Accu-Chek Safe-T-Pro Plus lancing device contains a sharps injury prevention feature where the lancet is retracted and concealed before and after use. Once the lancet is used, it is rendered inoperative. The device is designed for single use only. It has a 23 Gauge needle with 3 depth levels by twisting cap: 1.3 mm, 1.8 mm, 2.3 mm. It is spring-driven and loading/priming is not required. Press release button to activate lancet mechanism.
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K Number
K232509Device Name
Accu-Chek Safe-T-Pro Uno Lancing Device
Manufacturer
Roche Diabetes Care, Inc.
Date Cleared
2023-11-13
(87 days)
Product Code
FMK, QRK, QRL
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Roche Diabetes Care, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Accu-Chek Safe-T-Pro Uno lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.
Device Description
The Accu-Chek Safe-T-Pro Uno lancing device is a sterile, single-use, disposable lancing device intended to be used by non-professional users 18 years and older and healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
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K Number
K220849Device Name
Accu-Chek Safe-T-Pro Plus Lancing Device
Manufacturer
Roche Diabetes Care, Inc.
Date Cleared
2022-05-19
(57 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Roche Diabetes Care, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Accu-Chek Safe-T-Pro Plus lancing device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
Device Description
The Accu-Chek Safe-T-Pro Plus lancing device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
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K Number
K220364Device Name
Accu-Chek Safe-T-Pro Uno Lancing Device
Manufacturer
Roche Diabetes Care, Inc.
Date Cleared
2022-04-05
(56 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Roche Diabetes Care, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Accu-Chek Safe-T-Pro Uno Lancing Device is a sterile, single-use, disposable lancing device intended to be used by healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel.
Device Description
The Accu-Chek Safe-T-Pro Uno lancing device is a needle used for capillary blood sampling for use in diagnostic testing. The Accu-Chek Safe-T-Pro Uno lancing device contains a sharps injury prevention feature where the lancet is retracted and concealed before and after use. Once the lancet is used, it is rendered inoperative. The device is designed for single use only.
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K Number
K214022Device Name
Accu-Chek Softclix Blood Lancing System
Manufacturer
Roche Diabetes Care, Inc.
Date Cleared
2022-02-17
(57 days)
Product Code
QRL, FMK, ORK, ORL, QRK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Roche Diabetes Care, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Accu-Chek Softclix Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
This system is for use only on a single patient in a home setting.
This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
Device Description
The Accu-Chek Softclix Lancing Device uses compatible Accu-Chek Softclix Lancets to obtain a drop of blood from a fingertip or alternative sites. The Accu-Chek Softclix Blood Lancing System consists of three components:
1. Accu-Chek Softclix Lancing Device
2. Accu-Chek Softclix Lancets
3. Accu-Chek Softclix Alternative Site Testing (AST) Cap
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K Number
K160944Device Name
ACCU-CHEK Guide Blood Glucose Monitoring System
Manufacturer
Roche Diabetes Care, Inc.
Date Cleared
2016-08-31
(148 days)
Product Code
NBW, JJX, LFR
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
Roche Diabetes Care, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Accu-Chek Guide Blood Glucose Monitoring System is comprised of the Accu-Chek Guide meter and the Accu-Chek Guide test strips.
The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control.
The Accu-Chek Guide Blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes.
The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
This system is not for use in diagnosis or screening of diabetes mellitus, nor for neonatal use.
Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
Accu-Chek Guide Control Solutions are for use with the Accu-Chek Guide Blood Glucose Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.
Device Description
The Accu-Chek Guide System consists of the following:
- Accu-Chek Guide meter
- Accu-Chek Guide test strips
- Accu-Chek Guide control solutions (previously cleared in k043474)
The Accu-Chek Guide Blood Glucose Monitoring System makes use of the Accu-Chek Guide test strips, the Accu-Chek Guide meter, and the Accu-Chek Guide control solutions. This system is a single-patient use blood glucose monitoring system intended to be used to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. It should be noted that the Accu-Chek Guide control solutions are identical to the Accu-Chek Aviva control solutions that were cleared previously in k043474. The name has simply been updated to reflect their use with the Accu-Chek Guide system.
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